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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01403636




Trial ID
NCT01403636
Ethics application status
Date submitted
26/07/2011
Date registered
26/07/2011
Date last updated
17/02/2016

Titles & IDs
Public title
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
Scientific title
A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma
Secondary ID [1] 0 0
2011-001616-57
Secondary ID [2] 0 0
ARD12130
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAR245409

Experimental: mantle cell - 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose

Experimental: follicular lymphoma - 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose

Experimental: CLL/SLL - 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose

Experimental: Diffuse large B cell lymphoma - 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose


Treatment: Drugs: SAR245409
Pharmaceutical form:capsule Route of administration: oral

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)
Timepoint [1] 0 0
2 months to 2 years
Secondary outcome [1] 0 0
Progression free survival (PFS) at 6 months
Timepoint [1] 0 0
6 months to 2 years

Eligibility
Key inclusion criteria
Inclusion criteria:

- Tissue from an archived or fresh tumor sample

- A peripheral blood buffy coat sample is required for CLL/SLL.

- Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic
lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma

- Patient > or = 18 years old

- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2. Patients with
DLBCL will have ECOG < or = 1

- Adequate white blood cells and hemoglobin

- Good kidney and liver function

- Fasting glucose < 160 mg/dL

- No other malignancy

- Use of adequate birth control
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies
within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment

- Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of
the drug or its active metabolites (whichever is longer) of study enrollment

- Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with
temsirolimus is permitted in patients enrolled from countries where it is licensed for
this indication.

- Radiation therapy within 2 weeks of enrollment

- Autologous stem cell transplantation within 16 weeks of enrollment

- Prior allogeneic transplantation except for patients with R/R DLBCL who meet inclusion
criteria

- Central nervous system (CNS) or leptomeningeal involvement. Patients with DLBCL may
have active CNS or leptomeningeal involvement.

- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV)
serology

- Primary CNS lymphoma

- Primary mediastinal B-lymphoma

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Clayton
Recruitment hospital [2] 0 0
Investigational Site Number 036001 - Hobart
Recruitment hospital [3] 0 0
Investigational Site Number 036005 - Kingswood
Recruitment hospital [4] 0 0
Investigational Site Number 036003 - Perth
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
7001 - Hobart
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
West Virginia
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
France
State/province [15] 0 0
Montpellier
Country [16] 0 0
France
State/province [16] 0 0
Pierre Benite Cedex
Country [17] 0 0
France
State/province [17] 0 0
Rennes
Country [18] 0 0
France
State/province [18] 0 0
Rouen Cedex
Country [19] 0 0
France
State/province [19] 0 0
Villejuif Cedex
Country [20] 0 0
Germany
State/province [20] 0 0
Frankfurt Am Main
Country [21] 0 0
Germany
State/province [21] 0 0
Jena
Country [22] 0 0
Germany
State/province [22] 0 0
Ulm
Country [23] 0 0
Netherlands
State/province [23] 0 0
Amsterdam
Country [24] 0 0
Netherlands
State/province [24] 0 0
Groningen
Country [25] 0 0
Netherlands
State/province [25] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in
patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle
cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)

Secondary Objectives:

- To assess duration of response, progression free survival (PFS), and proportion of
patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or
DLBCL treated with SAR245409

- To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL
or DLBCL

- To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with
MCL, FL, CLL/SLL or DLBCL
Trial website
https://clinicaltrials.gov/show/NCT01403636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries